Fortrea Hiring Junior Regulatory Affairs Specialist in Pune

Fortrea, an Equal Opportunity Employer, is excited to announce a job opening for the position of “Junior Regulatory Affairs Specialist” in Pune, India. We are committed to fostering diversity and inclusion within our workforce and have a strict policy against any form of harassment or discrimination. At Fortrea, we base our employment decisions on business needs and individual qualifications, irrespective of factors such as race, religion, gender, age, or other legally protected characteristics. Join our team to embark on a journey of growth and innovation while upholding our values.

Vacancies List:

• Company Name: Fortrea
• Company Address: Pune, India
• Position Title: Junior Regulatory Affairs Specialist
• Salary: Commensurate with experience
• Job Requisition ID: 2362801
• Time Type: Full Time
• Posted on: Posted Today

Detailed Job Description:

Role: Junior Regulatory Affairs Specialist

Industry Type: Regulatory Affairs

Department: Regulatory and Quality

Employment Type: Full Time

Role Category: Junior Specialist

Key Responsibilities:

1. Prepare, compile & review Regulatory/Quality documents: Support submissions to various markets by preparing, compiling, and reviewing regulatory and quality documents.
2. Prepare deficiency responses: Review labeling information, product monographs, and marketing materials under supervision to address deficiencies.
3. Prepare post-approval supplements/annual reports: These are crucial to support changes and manage the regulatory product life cycle as applicable.
4. Seek guidance and enhance knowledge: Seek guidance from other team members and your manager as needed to enhance your regulatory knowledge and contribute effectively.
5. Perform additional duties: Fulfill additional responsibilities as assigned by your manager.
6. Create and revise raw material and packaging specifications: Utilize client global specification systems to create and/or revise specifications for raw materials and packaging.
7. Manage global change controls: Coordinate and manage global change controls related to revisions in raw material and packaging specifications.
8. Collaborate with internal departments: Interact with various internal departments such as Procurement, Analytical, Technical Assurance, and External manufacturers/sites, as well as Suppliers and Distributors. This interaction is vital to understand the change, impact assessment, implementation strategy, and required documentation governing the change.

Qualifications:

Education:

• UG: Relevant qualifications in the field

How to Apply:

We encourage interested candidates to apply for the position of Junior Regulatory Affairs Specialist at Fortrea